Pipeline Flex Embolization Device with Shield Technology
The Pipeline Flex Embolization Device with Shield Technology has incorrect label dimensions, being 2.50 mm instead of 3.00 mm.
Moderate risk
Using it may cause temporary or medically reversible health problems. Serious harm is unlikely.
FDA Class II recall · How risk is rated
What happened
Micro Therapeutics, Inc. recalled the Pipeline Flex Embolization Device with Shield Technology because the unit in packaging was 2.50 mm in diameter instead of the supposed 3.00 mm. The company began the recall on June 25, 2026, and the FDA added it to the Enforcement Report on September 28, 2026.
Summary by Recall Canary from the FDA notice.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Compare the details below with your product and check the FDA notice to confirm whether it is affected.
Product details
Pipeline Flex Embolization Device with Shield Technology REF PED2-300-12 UDI-DI code: 00763000448806 he Pipeline Flex Embolization Device with Shield Technology consists of a permanent implant combined with a guidewire based delivery system. The Pipeline Flex Embolization Device with Shield Technology implant
- UDI-DI
- 00763000448806
Details
- Company began the recall
- Event ID
- 99689
- Recall No.
- Z-3326-2026
- Company
- Micro Therapeutics, Inc.Irvine, California
- Hazard
- Labeling error
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
Summary updated
In FDA's weekly enforcement report
